FDA proposes action level for arsenic in apple juice

In a recent statement on its website the United States Food and Drug Administration (FDA) has proposed an "action level" for arsenic in apple juice to be set at 10 parts per billion (ppb) for inorganic arsenic in apple juice, which is the same level as that set by the U.S. Environmental Protection Agency (EPA) for arsenic in drinking water.

This should not be any cause for alarm because FDA testing and analysis is reported to confirm the overall safety of apple juice.

" The FDA is committed to ensuring the safety of the American food supply and to doing what is necessary to protect public health," said FDA Commissioner Margaret A. Hamburg, M.D.
" We have been studying this issue comprehensively, and based on the agency's data and analytical work, the FDA is confident in the overall safety of apple juice for children and adults."

" While the levels of arsenic in apple juice are very low, the FDA is proposing an action level to help prevent public exposure to the occasional lots of apple juice with arsenic levels above those permitted in drinking water," said Michael R. Taylor, the FDA's deputy commissioner for foods and veterinary medicine.

The FDA is establishing this threshold to provide guidance to industry. According to its recent statement the FDA takes the action level into account when considering possible enforcement action in the event of it becoming aware of a food product that exceeds the threshold.

Awareness of arsenic levels in apple juice is nothing new. The United States Food and Drug Administration has been monitoring the presence of arsenic in apple juice for 20 years and has recorded that, with few exceptions, the samples tested contained low levels of arsenic. New tools have enabled the FDA to understand more about the relationship between organic and inorganic arsenic levels. Last year the FDA released findings from its latest data collection and analysis of 94 samples of arsenic in apple juice. The analysis showed that 95% of the apple juice samples tested were below 10 ppb total arsenic; 100% of the samples were below 10 ppb for inorganic arsenic, the carcinogenic form of arsenic.

The proposed level of 10 ppb takes this sampling data into account together with information from a recently completed, peer-reviewed risk assessment of inorganic arsenic in apple juice conducted by FDA scientists. The assessment is based on lifetime exposure. Inorganic arsenic may be found in foods because it is present in the environment, both as a naturally occurring mineral and because of activity such as past use of arsenic-containing pesticides. A known carcinogen, inorganic arsenic has been associated with skin lesions, developmental effects, cardiovascular disease e.g. certain heart-related problems, neurotoxicity, and diabetes.

When conducting its new assessment on apple juice, the FDA was able to use data from two studies published in 2010, as well as a 2011 evaluation by the Joint Expert Committee on Food Additives and Contaminants of the Food and Agriculture Organization, part of the United Nations and the World Health Organization.
The FDA will continue to accept public comments on the proposed action level and the risk assessment for 60 days from 12 July 2013. Sources of further information are listed on its website.

Note: The FDA is an agency within the U.S. Department of Health and Human Services that protects public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. It is also is responsible for the safety and security of the USA's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. (This is understood to be correct as of July 2013.)

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